Fe Family Clinic Llc

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493. 1215 Condition: Hematology; 493. 1403 Condition: Laboratories Performing Moderate Complexity Testing; laboratory director; 493. 1421 Condition: Laboratories Performing Moderate Complexity Testing; testing personnel. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based upon review of policies and procedures, quality control records, patient test records, quality assurance reports and interview of facility personnel, the laboratory failed to meet the requirements for the specialty of hematology. Based upon review of policies and procedures, quality control records, patient test records and interview of facility personnel, the laboratory failed to test at least two levels of Hematology quality control material prior to testing 78 patient specimens on 10 of sixty one days in August and September of 2023. (See D 5447) Based upon review of policies and procedures, quality control records, patient test records, quality assurance reports and interview of facility personnel, the laboratory quality assurance program failed to identify that 78 patient specimens were tested and reported on 10 of sixty one days in August and September of 2023 without testing at least two level of quality control materials. (See D 5791) D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon review of policies and procedures, quality control records, patient test records and interview of facility personnel, the laboratory failed to test at least two levels of Hematology quality control material prior to testing 78 patient specimens on 10 of sixty one days in August and September of 2023. The findings included: 1. Review of the laboratory's quality assurance plan found on page 3 under the heading QUALITY CONTROL: "Quality control samples are analyzed each day of patient testing (as outlined in the technical procedure manual), and must be within acceptable limits before patient samples may be analyzed." 2. Review of the laboratory's own written policy titled Control Policy (dated 09/27/23) found on page 1: "For Quantitative testing, two levels of controls shall be run for every procedure on each day of use or for every eight hours of operation. Control materials should correlate with the specimen matrix. Controls will be evaluated daily against expected range then remedial actions must also be recorded. All control results shall be recorded and if controls are beyond the expected range then remedial actions must also be recorded. All controls results and remedial actions must be recorded and records kept for at least two years. Patient testing must not be performed or reported when control test results are outside the expected range." 3. Review of monthly quality control records for August and September 2023 found the laboratory failed to test at least two levels of quality control materials on 10 days as follows: August 1, 2023 August 2, 2023 August 3, 2023 August 4, 2023 August 7, 2023 August 8, 2023 August 9, 2023 September 25, 2023 September 26, 2023 September 27, 2023 4. Review of patient Sample Summary Reports found the laboratory tested 78 patient specimens in August and September without testing quality control materials as follows: August 1, 2023 - Patient sequence 543, 544, 545, and 546 August 2, 2023 - Patient sequence 553 and 554 August 3, 2023 - Patient sequence 559 August 4, 2023 - Patient sequence 565, 566, 567 and 568 August 7, 2023 - Patient sequence 574, 575, 576 and 577 August 8, 2023 - Patient sequence 582, 583, 584, 585, 586, 587, 588, 589 and 590. August 9, 2023 - Patient sequence 597, 598, 599 and 560 September 25, 2023 - Patient sequence 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074 and 1075 September 26, 2023 - Patient sequence 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1092, 1093, 1094 and 1095 September 27, 2023 - Patient sequence 1100, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110, 1111, 1112, 1113, 1114, 1115 and 1116 5. During interview of the clinical consultant conducted June 6, 2024 at 10:46 AM, he stated he did not know patient specimens were tested and reported without testing at least two levels of quality control materials D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based upon review of policies and procedures, quality control records, patient test records, quality assurance reports and interview of facility personnel, the laboratory quality assurance program failed to identify that 78 patient specimens were tested and reported on 10 of sixty one days in August and September of 2023 without testing at least two level of quality control materials. The findings included: 1. Review of the laboratory's quality assurance plan found on page 3 under the heading QUALITY CONTROL: "Quality control samples are analyzed each day of patient testing (as outlined in the technical procedure manual), and must be within acceptable limits before patient samples may be analyzed." 2. Review of the laboratory's own written policy titled Control Policy (dated 09/27/23) found on page 1: "For Quantitative testing, two levels of controls shall be run for every procedure on each day of use or for every eight hours of operation. Control materials should correlate with the specimen matrix. Controls will be evaluated daily against expected range then remedial actions must also be recorded. All control results shall be recorded and if controls are beyond the expected range then remedial actions must also be recorded. All controls results and remedial actions must be recorded and records kept for at least two years. Patient testing must not be performed or reported when control test results are outside the expected range." 3. Review of monthly quality control records for August and September 2023 found the laboratory failed to test at least two levels of quality control materials on 10 days as follows: August 1, 2023 August 2, 2023 August 3, 2023 August 4, 2023 August 7, 2023 August 8, 2023 August 9, 2023 September 25, 2023 September 26, 2023 September 27, 2023 4. Review of patient Sample Summary Reports found the laboratory tested 78 patient specimens in August and September without testing quality control materials as follows: August 1, 2023 - Patient sequence 543, 544, 545, and 546 August 2, 2023 - Patient sequence 553 and 554 August 3, 2023 - Patient sequence 559 August 4, 2023 - Patient sequence 565, 566, 567 and 568 August 7, 2023 - Patient sequence 574, 575, 576 and 577 August 8, 2023 - Patient sequence 582, 583, 584, 585, 586, 587, 588, 589 and 590. August 9, 2023 - Patient sequence 597, 598, 599 and 560 September 25, 2023 - Patient sequence 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074 and 1075 September 26, 2023 - Patient sequence 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1092, 1093, 1094 and 1095 September 27, 2023 - Patient sequence 1100, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110, 1111, 1112, 1113, 1114, 1115 and 1116. 5. Review of the monthly quality assurance reports for September and October 2023 found: September 10, 2023 - " I visited your office on September 6, 2023 and this is the monthly report. Hematology: Patient run and QC was compatible and suitably documented. The Levine Jennings curve was done and filed correctly. The maintenance was performed and placed in the books. The comparison report was done and logged accordingly." The review failed to identify patients tested between August 1-9, 2023 without testing quality control material and no remedial actions taken. October 27, 2023 - "I visited your office on October 27, 2023 and this is the monthly report. Hematology: Patient run and QC was compatible and suitably documented. The Levine Jennings curve was done and filed correctly. The maintenance was performed and placed in the books. The comparison report was done and logged accordingly." The review failed to identify patients tested between September 25-27, 2023 without testing quality control material and no remedial actions taken. 6. During interview of the technical consultant conducted June 6, 2024 at 11:57, he confirmed that he was hired as the technical consultant September 27, 2023. During his monthly visit in October 2023 he did not discover that patients had been tested and reported without quality control being tested. -- 3 of 7 -- D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based upon review of policies and procedures, quality control records, patient test records, quality assurance reports and interview of facility personnel, the laboratory director failed to provide oversight and direction of the moderate complexity laboratory performing Hematology testing. Based upon review of policies and procedures, quality control records, patient test records and interview of facility personnel, the laboratory failed to test at least two levels of Hematology quality control material prior to testing 78 patient specimens on 10 of sixty one days in August and September of 2023. (See D6020) Based upon review of policies and procedures, quality control records, patient test records, quality assurance reports and interview of facility personnel, the laboratory quality assurance program failed to identify that 78 patient specimens were tested and reported on 10 of sixty one days in August and September of 2023 without testing at least two level of quality control materials. (See D6021) D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based upon review of policies and procedures, quality control records, patient test records and interview of facility personnel, the laboratory failed to test at least two levels of Hematology quality control material prior to testing 78 patient specimens on 10 of sixty one days in August and September of 2023. (See D 5447) D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based upon review of policies and procedures, quality control records, patient test -- 4 of 7 -- records, quality assurance reports and interview of facility personnel, the laboratory quality assurance program failed to identify that 78 patient specimens were tested and reported on 10 of sixty one days in August and September of 2023 without testing at least two level of quality control materials. (See D 5791) D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found the laboratory director failed to ensure one of three testing personnel met minimum education requirements and had received appropriate training before testing patient specimens in Hematology. (See D 6065 and D6066) D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found that one of three testing personnel failed to have documentation available for review to ensure they met minimum education requirements and had received appropriate training before testing patient specimens in Hematology. (See D 6065 and D6066) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a -- 5 of 7 -- high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found that one of three testing personnel failed to have documentation available to ensure they met minimum education requirements for performing moderate complexity testing in Hematology. Findings included: 1. Review of the CMS report 209 Laboratory Personnel Report identified three testing personnel performing moderately complex testing. 2. Review of personnel records for testing person three (hired 05/13/2024) found no documentation of education available for review. 3. During interview of the technical consultant conducted June 6, 2024 at 12:10 PM, he confirmed that no education records were available for review for testing person three. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found that one of three testing personnel failed to have documentation of initial training for performing moderate complexity testing in Hematology. The findings included: 1. Review of the CMS report 209 Laboratory Personnel Report identified three testing personnel performing moderately complex testing. 2. Review of personnel records for testing person three (hired 05/13 /2024) found no documentation of initial training available for review. 3. During interview of the technical consultant conducted June 6, 2024 at 12:10 PM, he confirmed that no training records were available for review for testing person three. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based upon review of policies and procedures, quality control records, patient test records and interview of facility personnel, the testing personnel failed to test at least two levels of Hematology quality control material prior to testing 78 patient specimens on 10 of sixty one days in August and September of 2023. The findings included: 1. Review of the laboratory's quality assurance plan found on page 3 under the heading QUALITY CONTROL: "Quality control samples are analyzed each day of patient testing (as outlined in the technical procedure manual), and must be within acceptable limits before patient samples may be analyzed." 2. Review of the laboratory's own written policy titled Control Policy (dated 09/27/23) found on page 1: "For Quantitative testing, two levels of controls shall be run for every procedure on each day of use or for every eight hours of operation. Control materials should -- 6 of 7 -- correlate with the specimen matrix. Controls will be evaluated daily against expected range then remedial actions must also be recorded. All control results shall be recorded and if controls are beyond the expected range then remedial actions must also be recorded. All controls results and remedial actions must be recorded and records kept for at least two years. Patient testing must not be performed or reported when control test results are outside the expected range." 3. Review of monthly quality control records for August and September 2023 found the laboratory failed to test at least two levels of quality control materials on 10 days as follows: August 1, 2023 August 2, 2023 August 3, 2023 August 4, 2023 August 7, 2023 August 8, 2023 August 9, 2023 September 25, 2023 September 26, 2023 September 27, 2023 4. Review of patient Sample Summary Reports found the laboratory tested 78 patient specimens in August and September without testing quality control materials as follows: August 1, 2023 - Patient sequence 543, 544, 545, and 546 August 2, 2023 - Patient sequence 553 and 554 August 3, 2023 - Patient sequence 559 August 4, 2023 - Patient sequence 565, 566, 567 and 568 August 7, 2023 - Patient sequence 574, 575, 576 and 577 August 8, 2023 - Patient sequence 582, 583, 584, 585, 586, 587, 588, 589 and 590. August 9, 2023 - Patient sequence 597, 598, 599 and 560 September 25, 2023 - Patient sequence 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074 and 1075 September 26, 2023 - Patient sequence 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1092, 1093, 1094 and 1095 September 27, 2023 - Patient sequence 1100, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110, 1111, 1112, 1113, 1114, 1115 and 1116 5. During interview of the clinical consultant conducted June 6, 2024 at 10:46 AM, he stated he did not know patient specimens were tested and reported without testing at least two levels of quality control materials -- 7 of 7 --

Summary Statement of Deficiencies D0000 Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory's certificate of compliance, so that compliance with requirements can be determined. (c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance. The laboratory failed to notify HHS or its designee within 30 days of its change in director. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Medonic M-series hematology analyzer, review of patient test results, and staff interview, the laboratory failed to have documentation of a policy for resolving flags on CBC (complete blood count) results for 5 of 5 patient results that required follow up from April 1, 2022 to July 10, 2022. The findings were: 1. A review of the manufacturer's instructions for the Medonic M-series hematology analyzer (Art. no 1504283 December 2012) under the section titled "9.2 System Information Messages" revealed the manufacturer identified the following flags on CBC differential which required the laboratory to develop and follow its policy for the verification of the results: BD NM OM TM 2. A Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- sampling of patient test results from April 1, 2022 to July 10, 2022 identified the following patient results which were reported to the provider with flags on the differential portion of the results: Date Sequence ID Flag 04/27/2022 6572 SE, TM 04 /30/2022 6477 OM 05/04/2022 6629 OM 05/05/2022 6645 TM 07/06/2022 7179 OM 3. The laboratory was asked to provide documentation of a policy to resolve flags prior to their release to the healthcare provider. No documentation was provided. 5. An interview with the laboratory owner on July 11, 2022 at 1730 hours in the laboratory confirmed the findings. D5785

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of following the manufacturer's instructions for storage of AimStep Pregnancy test kits. The findings were: 1. Surveyor observation made on April 30, 2021 at 09:10 hours during the initial tour of the facility found two boxes of AimStep Pregnancy test kits stored in the small Kenmore refrigerator. Box 1 (two tests left in box) Lot # 91762 Expiration Date: 09-30-2021 Box 2 (30 of 30 tests left in box) Lot # 00993 Expiration Date: 09-30-2021 2. Review of the manufacturer's instructions (6#62-97030, Revised 02/11) under "Storage and Stability" it stated, "Store at room temperature (15 to 30 degrees Celsius). 3. The laboratory was asked to provide documentation of following the manufacturer's storage instructions for AimStep Pregnancy test kits. No documentation was provided. 4. An interview with the technical consultant on April 30, 2021 at 11:15 hours in the office confirmed the findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: I. Based on surveyor observation, review of manufacturer's instructions, review of quality control records, manufacturer's reagent specifications, patient test records, and confirmed in interview of facility personnel, the laboratory used expired quality control materials after their two-week opened and revised expiration date. The findings were: 1. Surveyor observation on April 30, 2021 at 09:10 hours during the initial tour of the facility found one set of Boule Con-Diff controls in the small Kenmore refrigerator with an open date of 04-29-2021. The surveyor then observed a second set of Boule Con-Diff controls in the large Kenmore refrigerator (same lot) with an open date of 04-09-2021. Because of the two-week opened and revised expiration date, the set of controls with an open date of 04-09-2021 expired on 04-22- 2021. 2. Review of Sysmex EIGHTCHECK 3WP X-TRA manufacturer's instructions (AQ578643C) under, "Storage and shelf life after first opening" it stated, "Opened and recapped vials and vials whose caps have been pierced will retain stability for 14 days if stored at 2-8 degrees Celsius after being re-capped." 3. Review of the laboratory's quality control records from April 1, 2021 to April 30, 2021 (the date of the onsite survey), found that the laboratory used expired quality control material on the following dates: April 23, 2021 April 26, 2021 April 29, 2021 4. Review of patient records found the following patients were tested when the laboratory used expired controls: Sequence # 3981 Test Date: 04-23-2021 Sequence # 3987 Test Date: 04-26- 2021 Sequence # 3991 Test Date: 04-26-2021 Sequence # 3990 Test Date: 04-26- 2021 Sequence # 3989 Test Date: 04-26-2021 Sequence # 4004 Test Date: 04-28- 2021 Sequence # 4005 Test Date: 04-28-2021 Sequence # 4006 Test Date: 04-28- 2021 Sequence # 4007 Test Date: 04-28-2021 5. The findings were confirmed in interview with the primary testing person April 30, 2021 at 11:15 hours in the laboratory. When asked if these were the only controls she had used in the last two weeks, she stated, "Yes." II. Based on review of quality control records, patient test records, and confirmed in interview of facility personnel, the laboratory used expired quality control materials the Medonic hematology analyzer on September 24, 2020 and then proceeded to test two patient samples. The findings were: 1. Review of the laboratory's quality control records from January 2020 to March 2021 found that the laboratory used expired quality control materials on the following patient test date: September 24, 2021 Note: The laboratory tested the expired controls on September 23, 2020, September 25, 2020, and September 28, 2020 but did not test any patients on those dates. 2. Review of patient records found the following patients were tested when the laboratory used expired controls: Sequence # 2874 Test Date: 09-24-2020 Sequence # 2873 Test Date: 09-24-2020 3. The findings were confirmed in interview with the technical consultant on April 30, 2021 at 11:15 hours in the office. III. Based on surveyor observation, and confirmed in interview of facility personnel, the laboratory failed to ensure that expired EDTA test tubes were not available for use in patient testing. The findings were: 1. Surveyor observation made on April 30, 2021 at 09:10 hours during the initial tour of the facility found 8 expired EDTA test tubes in a Styrofoam rack with two other lot numbers. Lot # 9260544 Expiration Date: 01-31- 2021 It could not be determined on the day of the survey that the test tubes had been used for patient testing. 2. An interview with the technical consultant on April 30, 2021 at 11:15 hours in the office confirmed the findings. Key: EDTA - ethylenediaminetetraacetic acid D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least -- 2 of 3 -- semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's testing personnel records and confirmed in interview of facility personnel, the technical consultant failed to perform competency assessments at least twice annually for 1 of 3 testing persons who required one. The findings were: 1. Review of personnel records for testing personnel #3 (as listed on Form CMS-209) revealed she had a hire date of 02-2019. By 02-2020 two competency assessments should have been available for review. There was only one competency assessment available for review. 2. An interview with the technical consultant on April 30, 2021 at 11:15 hours in the patient exam room confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API) . The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 493.807 (a) Reinstatement after Failure D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology. Refer to D2130 D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores from API found the laboratory failed to participate successfully for the analyte Red Blood Cells (RBC). Findings include: 1. The laboratory received the following failing scores (passing = >80%) for the analyte RBC: API 2017 3rd event laboratory received an unsatisfactory score of 0% for RBC. API 2018 1st event laboratory received an unsatisfactory score of 60% for RBC. API 2018 2nd event laboratory received an unsatisfactory score of 20% for RBC. 2. These three consecutive failures result in a second unsuccessful performance for the analyte RBC. 3. The laboratory must demonstrate sustained satisfactory performance (>80%) on two consecutive testing events for reinstatement. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and American Proficiency Institute records found that the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of hematology for the analytes Red Blood Cell (RBC) and Hematocrit. Findings include: 1. API 2018 1st event laboratory received an unsatisfactory score of 20% for RBC. 2. API 2018 2nd event laboratory received an unsatisfactory score of 20% for RBC. 3. API 2018 2nd event laboratory received an unsatisfactory score of 40% for hematocrit. -- 2 of 4 -- D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: D2122 Based on a proficiency testing desk review of CMS form 155 and API records found that the laboratory failed to attain an overall score of at least 80% for each testing event in the specialty of hematology. Findings: 1. API 2018-2nd event lab received a score of 76% for hematology testing event. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Hematology for RBC and Hematocrit. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings include: Findings include: 1. API 2017 3rd event laboratory received an unsatisfactory score of 0% for RBC. 2. API 2018 1st event laboratory received an unsatisfactory score of 60% for RBC. 3. API 2018 2nd event laboratory received an unsatisfactory score of 20% for RBC. 4. API 2017 3rd event laboratory received an unsatisfactory score of 0% for hematocrit. 4. API 2018 2nd event laboratory received an unsatisfactory score of 40% for hematocrit. Two out of three unsatisfactory scores results in unsuccessful PT performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently -- 3 of 4 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2130. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology. Refer to D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and American Proficiency Institute records found that the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of hematology. Findings: 1. API 2017 - 3rd event the laboratory received an unsatisfactory score of 0% for red blood cells (RBC). 2. API 2017 - 3rd event the laboratory received an unsatisfactory score of 0% hematocrit. 3. API 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for hemoglobin. 4. API 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for white blood cells (WBC). 5. API 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for platelets. 6. API 2018 - 1st event the laboratory received an unsatisfactory score of 60% for red blood cells (RBC). D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and API records found that the laboratory failed to attain an overall score of at least 80% for each testing event in the specialty of hematology. Findings: 1. API 2017 - 3rd event the laboratory received a score of 43% for hematology testing event. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Hematology. Two out of three unsatisfactory scores results in -- 2 of 3 -- unsuccessful PT performance. Findings: 1. API 2017 - 3rd event the laboratory received an unsatisfactory score of 0% for red blood cells (RBC). 2. API 2018 - 1st event the laboratory received an unsatisfactory score of 60% for red blood cells (RBC). D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2130 -- 3 of 3 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of patient records, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to ensure Henry Schein Helicobacter pylori tests were performed only on patients 19 years of age or older. The findings were: 1. Review of manufacturer's instructions stated, "This assay has not been established for patients less than 19 years of age." 2. Review of patient test logs revealed the following 3 of 3 patients who were tested when they were less than 19 years of age (see patient alias list). 3. The laboratory was asked to provide documentation of following the manufacturer's instructions to test only patients 19 years of age or older. No documentation was provided. 4. An interview with the technical consultant on 04/19 /2048 at 1245 hours in the patient exam room confirmed the findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)